title: Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial.
abstract: BACKGROUND
  Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth.
  
  
  METHODS
  We used a prospective, randomized, open-label, blinded-endpoint (PROBE) study design. Pregnant women presenting at <20 weeks gestation with singleton pregnancies self-collected a vaginal swab. Those who were asymptomatic and culture positive for Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg) or usual care (screening result is not revealed, no treatment). The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth <37 weeks gestation was also assessed.
  
  
  RESULTS
  Of 779 women approached, 500 (64%) participated in candidiasis screening, and 98 (19.6%) had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03.
  
  
  CONCLUSIONS
  A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609001052224.
authors.affiliation: Kolling Institute of Medical Research, University of Sydney, NSW Australia. clroberts@med.usyd.edu.au
authors.forename: Christine L
authors.initials: CL
authors.lastname: Roberts
authors.forename: Kristen
authors.initials: K
authors.lastname: Rickard
authors.forename: George
authors.initials: G
authors.lastname: Kotsiou
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Morris
mesh_terms: D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000627:therapeutic use*; D001315:Australia; D002175:Candida / Q000302:isolation & purification; D002181:Candidiasis, Vulvovaginal / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D003022:Clotrimazole / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D010865:Pilot Projects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011261:Pregnancy Trimester, First; D011262:Pregnancy Trimester, Second; D047928:Premature Birth / Q000209:etiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D003022:Clotrimazole